Reference:ICH ICH E8 Guideline R1 (2021) 5.: Difference between revisions
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{{:Document:ICH ICH E8 Guideline R1 (2021)}} | {{:Document:ICH ICH E8 Guideline R1 (2021)}} | ||
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! | ! colspan="2" class="gplx-infobox-header" | Reference Details | ||
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! Scope | |||
| HM | | HM | ||
|- | |- | ||
! | ! Document part | ||
| 5. | | 5. | ||
|- | |- | ||
! | ! Language | ||
| EN | | EN | ||
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! | ! Original entry by | ||
| Florian Adragna | | Florian Adragna | ||
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! | ! Contributors | ||
| | | | ||
|- | |- | ||
! | ! Tags (EN) | ||
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! | ! Tags (original language) | ||
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! | ! Tags (FR) | ||
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! | ! Comment | ||
| Design elements for master protocol and platform trial studies | | Design elements for master protocol and platform trial studies | ||
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== | == Content == | ||
5. DESIGN ELEMENTS AND DATA SOURCES FOR CLINICAL STUDIES | 5. DESIGN ELEMENTS AND DATA SOURCES FOR CLINICAL STUDIES | ||
[…] | […] | ||
Master protocol studies allow for the investigation of multiple drugs or multiple conditions under a shared framework. | Master protocol studies allow for the investigation of multiple drugs or multiple conditions under a shared framework. | ||
Platform studies allow for multiple drugs to be investigated in a continuous manner, with different drugs entering the study at different times and leaving the study based on pre-specified decision rules. | Platform studies allow for multiple drugs to be investigated in a continuous manner, with different drugs entering the study at different times and leaving the study based on pre-specified decision rules. | ||
Revision as of 14:27, 29 June 2026
| Document information | |
|---|---|
| Reference | ICH ICH E8 Guideline R1 (2021) |
| Validity area | ICH |
| Scope(s) | HM |
| Document name | ICH E8 Guideline |
| Version / Revision | R1 (2021) |
| Status | Current |
| Document type | International guideline |
| Language(s) | EN |
| Description | ICH guideline E8 (R1) on general considerations for clinical studies |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Scope | HM |
| Document part | 5. |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags (EN) | |
| Tags (original language) | |
| Tags (FR) | |
| Comment | Design elements for master protocol and platform trial studies |
Content
5. DESIGN ELEMENTS AND DATA SOURCES FOR CLINICAL STUDIES […] Master protocol studies allow for the investigation of multiple drugs or multiple conditions under a shared framework. Platform studies allow for multiple drugs to be investigated in a continuous manner, with different drugs entering the study at different times and leaving the study based on pre-specified decision rules.
